FDA Review Panel · OB

FDA 510(k) Obstetrics & Gynecology Devices

FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview

FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.

Key categories:

  • Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
  • Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
  • Breast pumps and lactation aids - electric and manual breast pumps
  • Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
  • Pregnancy test systems - hCG detection devices for professional and home use

4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3169 Obstetrics & Gynecology devices
2576–2600 of 3169
Cleared Dec 05, 1990
GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS
K904142 · Baxter Healthcare Corp
HET · Laparoscope, Gynecologic (and Accessories) · 89d
Cleared Nov 16, 1990
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
K902722 · Davol, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 149d
Cleared Nov 06, 1990
CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS
K903560 · Marlo Surgical Technology
HET · Laparoscope, Gynecologic (and Accessories) · 90d
Cleared Oct 31, 1990
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
K904273 · Carter Products
LTZ · Condom With Nonoxynol-9 · 44d
Cleared Oct 23, 1990
AUTO SUTURE LAPAROSCOPY ACCESSORY KIT
K903780 · United States Surgical, A Division of Tyco Healthc
HET · Laparoscope, Gynecologic (and Accessories) · 64d
Cleared Oct 22, 1990
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K903348 · Advanced Technology Laboratories, Inc.
HGL · Transducer, Ultrasonic, Obstetric · 88d
Cleared Oct 17, 1990
AUTO SUTURE(R) ENDOSCOPIC SCISSORS
K903206 · United States Surgical, A Division of Tyco Healthc
HET · Laparoscope, Gynecologic (and Accessories) · 89d
Cleared Oct 12, 1990
LAPAROSCOPIC ACCESS SHEATH SET
K903124 · Cook, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 88d
Cleared Oct 12, 1990
HYSTEROSCOPY SHEATH SET
K903146 · Cook, Inc.
HIH · Hysteroscope (and Accessories) · 86d
Cleared Oct 12, 1990
LAPAROSCOPIC CATHERTER
K903187 · Cook Ob/Gyn
HET · Laparoscope, Gynecologic (and Accessories) · 85d
Cleared Oct 11, 1990
AUTO SUTURE(R) ENDOSCOPIC CLAMP
K903205 · United States Surgical, A Division of Tyco Healthc
HDA · Forceps, Obstetrical · 83d
Cleared Oct 10, 1990
DAVOL SCOPE IRRIGATION SYSTEM
K901288 · C.R. Bard, Inc.
HIG · Insufflator, Hysteroscopic · 204d
Cleared Oct 05, 1990
MINISPACE(TM) IUI CATHETER
K902171 · Pharmacia, Inc.
HDR · Cap, Cervical · 144d
Cleared Oct 05, 1990
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL
K904358 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 11d
Cleared Sep 28, 1990
O. B. PACK IV
K902032 · Customed, Inc.
HFC · Aspirator, Endocervical · 147d
Cleared Sep 27, 1990
GARDOSI BIRTHING CUSHION
K903973 · Graphic Controls Corp.
KNC · Table, Obstetric (and Accessories) · 30d
Cleared Sep 26, 1990
TWIN BALLOON INJECTOR
K902975 · Zinnanti Surgical Instruments, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 82d
Cleared Sep 26, 1990
DEFLECTING WIRE GRASPER
K903707 · Cook, Inc.
HCZ · Forceps, Surgical, Gynecological · 42d
Cleared Sep 25, 1990
AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE
K903207 · United States Surgical, A Division of Tyco Healthc
HET · Laparoscope, Gynecologic (and Accessories) · 67d
Cleared Sep 24, 1990
CORE DISPOSABLE INSUFFLATION TUBING
K901413 · Core Dynamics, Inc.
HES · Insufflator, Carbon-dioxide, Uterotubal (and Accessories) · 182d
Cleared Sep 19, 1990
5 MM IRRIGATION/ASPIRATION FIBER PROBE
K902258 · Hgm Medical Laser Systems, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 121d
Cleared Sep 13, 1990
TEFLON CERVICAL ACCESS SET
K896701 · Cook Ob/Gyn
HDQ · Dilator, Cervical, Fixed Size · 289d
Cleared Sep 12, 1990
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
K900966 · Hitachi Medical Corp. of America
HGL · Transducer, Ultrasonic, Obstetric · 195d
Cleared Sep 05, 1990
SPIRTOS COAXIAL CATHETER SET
K896524 · Cook Ob/Gyn
HET · Laparoscope, Gynecologic (and Accessories) · 294d
Cleared Sep 04, 1990
MONOSCOPY(TM) BRAND, TROCAR REDUCER SET
K902563 · Dexide, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 85d

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All categories 3169 NUC Lubricant, Personal 230 HET Laparoscope, Gynecologic (and Accessories) 225 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 207 HIS Condom 199 HEB Tampon, Menstrual, Unscented 157 HGM System, Monitoring, Perinatal 155 HIH Hysteroscope (and Accessories) 145 HIF Insufflator, Laparoscopic 131 HIL Tampon, Menstrual, Scented, Scented-deodorized 75 HHD Pad, Menstrual, Unscented 64 LKF Cannula, Manipulator/injector, Uterine 61 HHL Pad, Menstrual, Scented, Scented-deodorized 45 MQK Labware, Assisted Reproduction 43 HIG Insufflator, Hysteroscopic 43